Fibrinogen as an Alternative to FFP in Aortic Surgery.

U

University of Edinburgh

Status and phase

Completed
Phase 4

Conditions

Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm Repair

Treatments

Biological: Fresh Frozen Plasma
Biological: Fibrinogen concentrate

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00994045
FIB692
EudraCT 2009-016709-41

Details and patient eligibility

About

Thoracoabdominal aneurysm (TAAA) repair is a major elective vascular operation associated with a large blood loss and potentially life-threatening clotting abnormalities. Theses clotting abnormalities are principally treated using fresh frozen plasma (FFP) (derived from human blood donations), the administration of which carries a number of risks including virus transmission (human immunodeficiency virus (HIV), hepatitis B, hepatitis C) and infection with variant Creutzfeld-Jacob disease (vCJD). FFP is no longer administered to children or high-usage adults in the UK because of the infection risk, and recently it was decided by a UK advisory body that the use of UK-derived FFP should cease. Fibrinogen concentrate is an alternative treatment option to FFP which is thought have less infection risk (purified, heat treated) and has been in licensed use for many years in other European countries. The investigators have been using fibrinogen concentrate recently in their department as an alternative to FFP with encouraging results. 20 patients undergoing elective TAAA repair at The Royal Infirmary of Edinburgh will be randomly allocated to receive standard treatment (FFP) or fibrinogen concentrate as treatment for clotting abnormalities during their surgery. The investigators will take a number of additional blood samples which will provide valuable information about the pattern of clotting abnormalities during this type of operation. The investigators will also record blood loss and the number of allogeneic (derived from human donors) blood components transfused to the patient (red cells, FFP and platelets). Our primary objective is to assess the pattern of coagulation abnormalities in both groups. We will also examine whether the use of fibrinogen concentrate during TAAA repair avoids the need to administer FFP.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Undergoing elective thoracoabdominal aneurysm repair.
  • Over 18 years of age.
  • Able to give written informed consent.

Exclusion criteria

  • Previous aortic surgery (re-do surgery).
  • Emergency surgery.
  • Pregnancy.
  • Females of child-bearing age (less than 45 years) not using medically approved method of contraception.
  • Congenital or acquired coagulopathy.
  • Known allergy to study drug.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Fresh Frozen Plasma
Active Comparator group
Treatment:
Biological: Fresh Frozen Plasma
Fibrinogen concentrate
Experimental group
Treatment:
Biological: Fibrinogen concentrate

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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